Compositions containing plant mucilage

ABSTRACT

A body lubricating, moisturizing, anti-inflammatory, and anti-pain formulation utilizes a mucilage-containing extract derived from a plant such as okra, Abelmoschus esculentus (Hibiscus esculentus). The formulation can be provided as a free liquid such as a solution, suspension, foam, gel, cream, ointment, or spray or alternatively impregnated into an absorbent solid article such as a mask, a wipe, swab, a bandage, cloth pad or a gauze. Application of the formulation to a mucosal or external bodily tissue result in the application of a layer of mucilage that lubricates and moisturizes the tissue as well as protects it from external damage from foreign particles and UV irradiation. Application of the formulation to an inflamed tissue provides anti-inflammatory effects and relieves pain.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part application of U.S. patentapplication Ser. No. 16/727,433, filed Dec. 26, 2019; which is acontinuation of U.S. patent application Ser. No. 16/175,451, filed Oct.30, 2018, which issued as U.S. Pat. No. 10,517,815 on Dec. 31, 2019;which is a continuation of U.S. patent application Ser. No. 15/087,267,filed Mar. 31, 2016, which issue as U.S. Pat. No. 10,117,826 on Nov. 6,2018; all of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates generally to the fields of bodilylubrication and minimization of inflammation. More specifically, thepresent disclosure provides a formulation comprising plant mucilage forlubricating and moisturizing bodily surfaces, both external and mucosal,for anti-inflammation, and for pain control.

Description of the Related Art

Lubrication plays vital roles in the healthy maintenance of numerousbodily functions. The specific roles vary by the bodily tissue inquestion.

Tears act as a lubricant for the eyes. Normal ocular function isdepending on a clear and smooth layer of tears to support criticalocular surface functions. Tears coat the corneal and conjunctivalepithelium to prevent the cells from drying out like those of the skinepithelium, which is a composed of dead cells. With each blink, thetears reduce surface abrasive effect between the eyelid and the cornealsurface. The lack of lubrication on the eyes can lead to symptoms ofirritation, scratchiness, dryness, and redness. It can also producescarring, pain, and permanent vision loss.

Saliva is a viscous fluid that acts as the natural lubricant for themouth. It coats the teeth to prevent tooth decay. It keeps the mouthmoist and hydrates food for chewing. The lack of saliva leads to chronicteeth decay, bad breath, swallowing difficulty, and infections.

Even though skin is composed of a layer of dead epithelial cells,lubrication is still needed to maintain the integrity and pliability ofthe skin. The loss of skin moisture leads to dry, cracked, and flakyskin that increases the risk for infection, bleeding, and pain.

The outer walls of the vagina are coated with a layer of moisture forsurface protection, which functions as a natural lubricant for sexualactivity and as a barrier to infection and inflammation. The lack ofvaginal lubrication can lead to urinary infections, painful intercourse,bleeding, and pain. Lubrication of the rectum performs similar roles.

Mucilage is a viscous gel-like liquid produced by most plants andcertain microorganisms. Mucilage is made up of a combination ofpolysaccharides and proteins. Plants utilize mucilage in diverse lifeprocesses such as water storage and seed germination. Individual speciesof plants vary in the amount of mucilage produced thereby. Examples ofplants containing especially high levels of mucilage include variouscacti, kelp, various carnivorous plants, mallows, marshmallows,liquorice root, Psyllium, slippery elm bark, and okra, among others.

Okra is a member of the mallow family commonly known for its edible podsrich in mucilage. The current official taxonomic name for okra isAbelmoschus esculentus. The Abelmoschus genus comprises fifteen speciesof the mallow family, which were formerly classified within the Hibiscusgenus. Under the old classification scheme, okra was known as Hibiscusesculentus, and this old name is still in common usage. Olderclassification names for okra from other classification systems includeAbelmoschus bammia; Abelmoschus longifolius; Abelmoschus officinalis;Abelmoschus praecox; Abelmoschus tuberculatus; Hibiscus hispidissimus;Hibiscus longifolius; and, Hibiscus praecox.

The use of okra mucilage as a lubricant for mechanical purposes is knownin the previous art. Related U.S. Pat. No. 5,851,963 (O'Bryant, OrganicLubricant, Dec. 22, 1998) and U.S. Pat. No. 6,124,248 (O'Bryant, et al.,Organic Lubricants and Coolants, Sep. 26, 2000) provide biodegradableindustrial and machining lubricants and coolants derived from mucilageand mucilage extracts. In one embodiment, the mucilage extract isderived from okra, especially okra pods.

U.S. Pat. No. 9,163,374 (Alcantar, et al., Use of cactus mucilage as adispersant and absorbent for oil in oil-water mixtures, Oct. 15, 2015)teaches the use of cactus and Hibiscus esculentus mucilage to remove oilcontaminants from water. This method is especially intended for use incleaning up oil spills.

The prior art also includes previous biomedical applications of okraextracts.

U.S. Pat. No. 4,014,335 (Arnold; Randall K., Ocular Drug DeliveryDevice, Mar. 29, 1977) teaches the use of okra gum as one of a number ofpossible drug carriers in a three-layered laminate ocular drug deliverydevice taught and claimed therein.

U.S. Pat. No. 4,154,822 (Polimeni et al., Polysaccharide for Enhancementof Cardiac Output, May 15, 1979) utilizes polysaccharide substances,preferably derived by extraction and purification of okra plantmaterials, to provide selective rheological and hemodynamic effects uponbiomedical cardiac administration. This method is specifically intendedto enhance cardiac output without substantial increments in circulatory(plasma) volume or concurrent inotropic, chronotropic or vasoactiveeffects.

U.S. Pat. No. 8,628,816 (Henry et al., Product to reduce glycemicresponse of carbohydrate based foods, Jan. 14, 2014) teaches a methodfor reducing the glycemic index of a premixed flour by adding variouspulverized plant materials, including okra, to the flour. Thespecification of the patent indicates that the mucilage in the okraplays an important role in reducing the glycemic index of the resultingflour.

US Patent Application No. 20140303094 (Bastia et al., Composition andUse Thereof in the Treatment of Anal Rhagades, Oct. 9, 2014) teaches amedicament for the treatment of anal rhagades that comprises at leastone protein extract and/or at least one beta glucan from Hibiscus. TheHibiscus in question can be Hibiscus esculentus.

The prior art is deficient in the lack of an okra mucilage containinglubricating and moisturizing formulation for external and mucosal bodysurfaces. The present disclosure addresses this lack.

SUMMARY OF THE INVENTION

An embodiment of the disclosure is a formulation for lubricating,moisturizing, anti-inflammation, and for pain control for application toa bodily tissue (examples include but are not limited to skin, joints,subcutaneous tissue, visceral organs, mucosal membrane, cartilage, gum,tendons) comprising mucilage extracted from one or more plant species,wherein the formulation is intended to be applied to a bodily tissue. Inan embodiment, the plant species is from a plant genus selected from thegroup comprising Abelmoschus and Hibiscus. In an embodiment, wherein themucilage is extracted from Abelmoschus esculentus (Hibiscus esculentus).In an embodiment, the mucilage is extracted from plant material selectedfrom the group comprising fresh plant material, frozen plant material,dried plant material, and powdered plant material. In an embodiment, theformulation is buffered to a pH range of about 5.5 to 8.0. In anembodiment, the formulation is buffered to a pH of about 6.5. In anembodiment, the formulation is buffered with one of more salts selectedfrom the list comprising sodium chloride, sodium lactate, potassiumchloride, and calcium chloride. In an embodiment, the formulationfurther comprises one or more cationic, anionic, nonionic, or amphotericsurfactants. In an embodiment, the one or more surfactants are selectedfrom the group comprising cocamidopropyl betaine disodium laurethsulfosuccinate; cetalkonium chloride; decyl glucoside; disodiumcocoamphodiacetate; and glycerin. In an embodiment, the formulationfurther comprises one or more emollients. In an embodiment, the one ormore emollients are selected from the group comprising Aloe barbadensisleaf juice; and glycerin. In an embodiment, the formulation furthercomprises one or more antioxidants. In an embodiment, the one or moreantioxidants are selected from the list comprising Rubus idaeus(Raspberry) seed oil and Citrus unshiu peel extract. In an embodiment,the formulation further comprises caffeine as an antioxidant; sodiumphytate as a chelating agent; hydrolyzed soy protein as a moisturizer;ethylhexylglycerin as a conditioning agent and preservative; andphenoxyethanol as a preservative. In an embodiment, the formulation isprovided in a form selected from the group comprising a wipe; a swab; abandage; a gauze; a suspension; a foam; and a spray.

An embodiment of the disclosure is a lubricating, moisturizing,anti-inflammatory, and anti-pain formulation comprising Abelmoschusesculentus (Hibiscus esculentus) (okra) mucilage; Rubus idaeus(raspberry) seed oil; Citrus unshiu peel extract; Aloe barbadensis leafjuice; sodium phytate; phenoxyethanol; ethylhexylglycerin; wherein theformulation is buffered to a pH range of about 5.5 to 8.0. In anembodiment, the Abelmoschus esculentus (Hibiscus esculentus) mucilagehas been extracted from plant material selected from the groupcomprising fresh plant material, frozen plant material, dried plantmaterial, and powdered plant material. In an embodiment, the Abelmoschusesculentus (Hibiscus esculentus) mucilage is extracted from powderedokra.

In an embodiment, the formulation is provided in a form selected fromthe group comprising a wipe; a swab; a bandage; a gauze; a suspension; afoam; and a spray.

An embodiment of the disclosure is an eyelid cleansing and moisturizingwipe, the wipe comprising a cloth pad impregnated with a formulationcomprising Abelmoschus esculentus (Hibiscus esculentus) (okra) mucilage;Rubus idaeus (raspberry) seed oil; Citrus unshiu peel extract; Aloebarbadensis leaf juice; disodium laureth sulfosuccinate; cetalkoniumchloride; decyl glucoside; disodium cocoamphodiacetate; glycerin;caffeine; sodium phytate; hydrolyzed soy protein; phenoxyethanol;ethylhexylglycerin; sodium chloride; sodium lactate; potassium chloride;and calcium chloride; wherein the formulation is buffered to about pH6.5.

A body lubricating, moisturizing, and anti-inflammatory formulationcomprising plant mucilage is provided by the disclosure described andclaimed herein. More specific embodiments of the described formulationutilize plant mucilage extracted from a species of either theAbelmoschus or Hibiscus genus, especially mucilage from okra(Abelmoschus esculentus, still commonly described by its olderscientific classification name Hibiscus esculentus).

A number of other components can be included in the formulation toimprove its properties and function. Rubus idaeus (raspberry) seed oiland Citrus unshiu peel extract can be added to provide antioxidantproperties. Surfactant activity can be incorporated into the formulationby introducing disodium laureth sulfosuccinate, cetalkonium chloride;decyl glucoside, disodium cocoamphodiacetate and/or glycerin. Glycerincan also be added as an emollient in the formulation. Aloe barbadensisleaf juice can also be used as an additional emollient. Caffeine is auseful addition for its antioxidation properties. Sodium phytate can beadded as a chelating agent. Moisturizers such as hydrolyzed soy proteinand ethylhexylglycerin can play useful roles in the formulation.Ethylhexylglycerin also has preservative qualities and can be includedalong with phenoxyethanol for this purpose.

This formulation can be proved as a free liquid solution, suspension,foam, gel, cream, ointment, or spray. Alternatively, the formulation canbe impregnated onto a wipe, a swab, a bandage, or gauze. An eye wipecomprising a cloth pad wetted with the above formulation is specificallyprovided and claimed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

So that the matter in which the above-recited features, advantages andobjects of the disclosure, as well as others which will become clear,are attained and can be understood in detail, more particulardescriptions of the disclosure briefly summarized above can be had byreference to certain embodiments thereof which are illustrated in theappended drawings. These drawings form a part of the specification. Itis to be noted, however, that the appended drawings illustrate preferredembodiments of the disclosure and therefore are not to be consideredlimiting in their scope.

FIG. 1 illustrates the protective qualities of the lubricating andmoisturizing formulation of the instant disclosure. FIG. 1 shows abiological tissue both before and after the application of thelubricating and moisturizing mucilage formation provided herein. Priorto the application of the mucilage formulation, the tissue is moresusceptible to damage by foreign particles and UV rays as well as waterloss through evaporation. Application of the mucilage containinglubricating and moisturizing formulation provides a protective barrieragainst both foreign particles and UV rays as well as aiding in waterretention.

FIG. 2 illustrates various inflammation pathways and the effect of themucilage-based platform described herein.

FIG. 3A-3D depict photographs of the eyelid and eyelashes of patientswith blepharitis. FIGS. 3A-3C depict cylindrical dandruff present at theeyelash roots (arrows).

FIG. 3D does not depict cylindrical dandruff present at the eyelashroots.

FIG. 4 depicts a view of Demodex folliculorum adult and egg formslocated on an eyelash follicle. Inceboz et al. (2009).

FIG. 5 illustrates the kill time of the formulation (Zocular) and normalsaline.

FIG. 6 depicts the results of dry eye treatment using Zocular okra-basedpolysaccharides. The graph shows the results of the Standard PatientEvaluation of Eye Dryness (SPEED) questionnaire at baseline beforetreatment and 2 hours after treatment with the ZocuKit (for ZESTtreatment), a disposable kit that contains lid cleaning accessories anda gel with okra-based polysaccharides.

FIG. 7A depicts dry eye symptoms associated with contact lens use asmeasured with the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8), whichshows improved (lower) scores after Zocular Eyelid System Treatment(ZEST) treatment.

FIG. 7B depicts improved (lower) Ocular Surface Disease Index (OSDI)scores after ZEST treatment.

FIG. 7C depicts increased contact lens (CL) wear time after ZESTtreatment.

FIG. 7D depicts the disappearance of the inflammatory marker MatrixMetallopeptidase-9 (MMP-9) after ZEST treatment for the right eye(oculus dexter (OD)) and left eye (oculus sinister (OS)).

DETAILED DESCRIPTION OF THE INVENTION

Therefore, if appearing herein, the following terms shall have thedefinitions set out below.

Lubricate, as used herein, refers to the addition of anything whichreduces friction.

Moisturize, as used herein, describes an action that increases watercontent or aids in water retention in a biological tissue.

Inflammation, as used herein, is a pathologic response that can beprovoked by physical, chemical, and biologic agents. The response caninclude but is not limited to cytologic changes, cellular infiltration,and/or mediator release. Pain is the subjective sensation of discomfortthat can vary from mild to unbearable. The neural sensors for pain,called nociceptors, can be classified according to the type of stimulusthat triggers them. Hence there are chemical nociceptors, thermalnociceptor, mechanical nociceptors, and some nociceptors respond tomultiple types of painful stimuli. The final pathway for all clinicallyrelevant pain is inflammatory pain, which occurs when there has beendamage to tissue from mechanical, thermal, or chemical injury or whenthere is an autoimmune type injury where the inflammation is due to anintrinsic rather than an extrinsic process. As an example, pinching onthe skin activates the mechanical nociceptors but the pain from thepinch will quickly dissipates once the force of the pinch has beenremoved. However, if the force of the pinch is strong enough to causetissue damage, there will be secondary inflammatory pain that will notquickly improve even if the mechanical nociceptors are no longeractivated.

Mucilage, as used herein, is a polysaccharide substance extracted as aviscous or gelatinous solution from plants and microorganisms. Mucilagecan also contain proteins and plays a variety of roles in plant lifefunctions. Isolated mucilage can be used as a lubricant.

As used herein, a surfactant is a chemical compound, usually organic,used to reduce the surface tension between two liquids or between aliquid and a solid. Various detergents, wetting agents, emulsifiers,foaming agents, and dispersants are among the agents that can be used assurfactants.

As described herein. a moisturizer is a chemical substance orcombination thereof which hydrates biological tissues, usually bypreventing water evaporation from the tissues.

An emollient, as used herein, is a compound or mixture of compounds thatare used to moisturize skin to reduce water loss and provide aprotective cover. Applications of emollients to skin have a soothing andsmoothening effect on the skin, making the skin softer and more pliable.

A conditioning agent, as used herein, refers to any compound orcombination thereof, provide a soft improved feel and texture to abiological tissue. Conditioning agents are added to various creams andlotions, gels, serums, facial spray mists, skin toners, shampoos, hairstyling gels, hair sprays and hair conditioners.

As used herein, antioxidants are molecules that prevent oxidation. Bypreventing oxidation, antioxidants protect biological tissues from boththe oxidation process itself and from the free radicals that can beproduced during the same process. The production of free radicals canresult in chain reactions that can result in considerable damage tobiological tissues. Various thiols such as glutathione and ascorbic acid(vitamin C) are examples of antioxidants.

A vasoconstrictor, as used herein, is a chemical agent that narrowsblood vessels by contracting the muscular wall of the vessels. Thisresults in reduce blood flow to the affected area. This has a coolingeffect on the affected tissue.

A chelating agent is an organic molecule which can bind a metal or metalion. Chelating agents are useful for removing metal and metal ions froman environment by binding and thus sequestering them.

A buffer, as used herein, refers to anything that stabilizes the pH of asolution. Various chemicals and salt combinations are effective buffers.

A preservative, as used herein, refers to a chemical that is added toproducts such as food, beverages, pharmaceutical drugs, paints,biological samples, cosmetics, wood, and many other products to preventeither chemical or microbial degradation of the product in question.

In an embodiment, the formulation can be used to treat mammals. In anembodiment, the formulation can be used to treat humans.

The body formulation described and claimed herein has anti-inflammatoryproperties for biological tissues. Inflammation is characterized by therelease of inflammatory mediators such cytokines, prostaglandins, andhistamines. The three major components of the inflammatory processare 1) hemodynamic changes; 2) increased capillary permeability; and 3)leukocytic exudation. The signs of inflammation include some or allof 1) heat; 2) redness; 3) swelling; 4) pain; and 5) loss of function orstructural integrity. In an embodiment, the inflammation can be aphthousulcer, arteritis, arthritis, balanitis, blepharitis, bronchitis,bursitis, cellulitis, cheilitis, cholecystitis, colitis, conjunctivitis,dermatitis, encephalitis, endocarditits, enteritis, episcleritis,esophagitis, funiculitis, gastritis, gingivitis, glossitis, hepatitis,keratitis, laryngitis, lymphadenitis, meibomianitis meningitis,metritis, myelitis, myocarditis, myositis, nephritis, odontitis,omphaloitis, oophoritis, ophthalmitis, orchititis, osteitis,osteomyelitis, otitis, pericarditis, splenitis, tracheitis, periostitis,and vaginitis. In an embodiment, the inflammation can be other than at alocation mentioned above. In an embodiment, the inflammation can besecondary to a primary infection, cancer, or photodamage from lasers,x-rays, gamma rays, or sun exposure. In an embodiment, the compositioncan be used to treat dry eyes, dry socket, acne, pain, wrinkles, finelines on skins, or numb tissue. FIG. 2 illustrates various inflammationpathways and the effect of the mucilage-based platform described herein.

In an embodiment, the % range can refer to about the lower percentage toabout the higher percentage.

The formulation is able to reduce acute pain within minutes (or secondson mucosal tissue). Applying the formulation to an inflamed joint willresult in a 60-90% reduction in pain within 15-20 minutes that will lastfor hours, with the duration of relief increasing over time. Theformulation is able to be absorbed through the skin.

The body formulation described and claimed herein is capable oflubricating and moisturizing both mucosal and external biologicaltissues (FIG. 1) and acting as an anti-inflammatory (FIG. 2). Theformulation in question utilizes mucilage extracted from plant materialsfrom one or more plant species to achieve this end. The formulation inquestion can also be used an anti-inflammatory or anti-pain agent over asmall area or in low or minute dosage where its lubricating ormoisturizing effects would not be as significant as its anti-pain oranti-inflammation effects. The mucilage can be extracted from a numberof different types of plant materials including fresh plant material,frozen plant material, dried plant material, and powdered plantmaterial. The concentration of plant mucilage in the formulation canrange from 0.001 to 5.0%.

In more specific embodiments of the instant disclosure, the mucilagecontaining extract is derived from one or more plant species of eitherthe Abelmoschus genus or the Hibiscus genus of plant species. In apreferred embodiment of the instant disclosure, the mucilage is derivedfrom the okra plant, also known by its current scientific nameAbelmoschus esculentus and formerly known as Hibiscus esculentus.

The body lubricating and moisturizing formulation can be buffered to apH range of about 5.5 to 8.0. Buffering the formulation to about pH 6.5is an embodiment of the instant disclosure. This can be accomplishedwith a combination of salts including but not limited to sodiumchloride, sodium lactate, potassium chloride, and calcium chloride. Therelative amount of each salt is balanced to achieve the desired pH. Theconcentrations of the individual salts can range from 0.001-2.0% in theinstant disclosure.

The formulation of the instant disclosure can also include surfactants.Possible surfactants and possible concentration thereof include:disodium laureth sulfosuccinate (0.01-12%); cetalkonium chloride(0.01-40%); decyl glucoside (0.01-12.0%), disodium cocoamphodiacetate(0.01-4.0%); and glycerin (0.008-0.5%). The formulation can also includeone or more emollients, which can include Aloe barbadensis leaf juice(0.05-4.0%). and glycerin (0.008-0.5%).

One or more antioxidants can be included in the formulation of theinstant disclosure to prevent oxidative damage to the tissues to whichit is applied. Rubus idaeus (Raspberry) seed oil (0.03-1.0%) and Citrusunshiu peel extract (0.01%-1.0%) are preferred antioxidants.

A number of additional components can be incorporated in the lubricatingand moisturizing formulation. Caffeine, at concentration range0.05-0.5%, can be added as an antioxidant. Sodium phytate (concentrationrange of 0.02-1.0%) can be included as a chelating agent. Includinghydrolyzed soy protein at 0.025-3.0% concentration increases the abilityof the formulation to moisturize bodily tissues. 0.001-1.0%ethylhexylglycerin is a useful addition as a preservative carrier agent.The preservative phenoxyethanol can also be used at a concentrationrange of 0.01-1.0%. In an embodiment, the composition is comprised ofthe contents of Table 1.

TABLE 1 Substance Range (%) (w/v) Plant mucilage 0.001-5.0  Emollients(at least one): aloe barbadensis leaf juice 0.05-4.0  glycerin0.008-0.5  Antioxidants (at least one): Rubus idaeus seed oil 0.03-1.0 Citrus unshiu peel extract 0.01-1.0  Chelating agent (optional): sodiumphytate 0.02-1.0  Preservative carrier agent (optional)ethylhexylglycerin 0.001-1.0  phenoxyethanol 0.01-1.0  Water 60-95

In an embodiment, the composition is comprised of the contents of Table2.

TABLE 2 Substance Range (%) (w/v) Plant mucilage 0.001-5.0  Salts (atleast one): sodium chloride 0.001-2.0  sodium lactate 0.001-2.0 potassium chloride 0.001-2.0  calcium chloride 0.001-2.0  Surfactants(at least one): disodium laureth sulfosuccinate  1.0-12.0 decylglucoside  1.0-12.0 disodium cocoamphodiacetate 0.1-4.0 glycerin0.008-0.5  cetalkonium chloride 0.01-40  Emollients (at least one): aloebarbadensis leaf juice 0.05-4.0  glycerin 0.008-0.5  Antioxidants (atleast one): Rubus idaeus seed oil 0.03-1.0  Citrus unshiu peel extract0.01-1.0  Caffeine (optional) 0.05-0.5  Chelating agent (optional):sodium phytate 0.02-1.0  Hydrolyzed soy protein (optional) 0.025-3.0 Preservative carrier agent (optional) ethylhexylglycerin 0.001-1.0 Preservative (optional): phenoxyethanol 0.01-1.0  Fragrance   0-0.25Water 60-95

In an embodiment, the composition does not contain at least oneingredient from each row shown in Table 1. In an embodiment, thecomposition contains at least plant mucilage. In an embodiment, thecomposition does not include surfactants or emulsifiers. In anembodiment, the composition contains plant mucilage, at least oneemollient, at least one antioxidant, a chelating agent, and water. In anembodiment, the composition contains plant mucilage, at least oneemollient, at least one antioxidant, a chelating agent, water, and atleast one preservative carrier agent. In an embodiment, the compositiondoes not include at least one salt, at least one surfactant, caffeine,and at least one preservative carrier agent and fragrance. In anembodiment, the composition includes no preservative. In an embodiment,a sterile production process and/or packaging is used. In an embodiment,the composition does not include water. In an embodiment, thecomposition includes oil or a non-aqueous carrier.

The body lubricating, moisturizing, anti-inflammatory formulation of theclaimed herein can be provided in a number of possible forms. Freeliquid or fluid forms include solutions, parenteral, intravenous,intrathecal, gels, creams, ointments, suspensions, foams, and sprays.Alternatively, the formulation can be impregnated onto a physical objectsuch as a wipe; a swab; a bandage; a transdermal patch; or a gauze.

In an embodiment, the effect of the formulation lasts at least 10-60minutes. In an embodiment, the effect of the formulation lasts at least1-24 hours.

A preferred embodiment of the instant disclosure is a body lubricatingand moisturizing formulation comprising a combination of Abelmoschusesculentus (Hibiscus esculentus) (okra) mucilage; Rubus idaeus(raspberry) seed oil; Citrus unshiu peel extract; Aloe barbadensis leafjuice; cocamidopropyl betaine; disodium laureth sulfosuccinate;cetalkonium chloride; decyl glucoside; disodium cocoamphodiacetate;glycerin; caffeine; sodium phytate; hydrolyzed soy protein;phenoxyethanol; ethylhexylglycerin; sodium chloride; sodium lactate;potassium chloride; and, calcium chloride. The above combination can bebuffered to a pH range of 5.5 to 8.0, with 6.5 being a preferred pH. TheAbelmoschus esculentus mucilage can be derived from at least one offresh plant material, frozen plant material, dried plant material, andpowdered plant material. The particular embodiment described in theexamples provided herein utilizes powdered okra. This solution can beprovided as a free suspension or solution, possibly as a foam or spray.In an embodiment, the liquid can be applied using a dropper.Alternatively, the formulation can be provided as liquid absorbed onto amask, a wipe, a swab, a bandage, or gauze.

Another preferred embodiment of the instant disclosure is an eyelidcleansing and moisturizing eye wipe wetted with the formulationdescribed and claimed herein. Specifically, this formulation is amixture of Abelmoschus esculentus (Hibiscus esculentus) (okra) mucilage;Rubus idaeus (raspberry) seed oil; Citrus unshiu peel extract; Aloebarbadensis leaf juice; disodium laureth sulfosuccinate; cetalkoniumchloride; decyl glucoside; disodium cocoamphodiacetate; glycerin;caffeine; sodium phytate; hydrolyzed soy protein; phenoxyethanol;ethylhexylglycerin; sodium chloride; sodium lactate; potassium chloride;and, calcium chloride; wherein the formulation is buffered to a pH rangeof about 5.5 to 8.0. In an embodiment, the pH is about 6.5.

The following examples are embodiments of the disclosure and are notmeant to limit the present disclosure in any fashion.

Example 1

Preparation of Mucilage

The mucilage can be prepared by any method or purchased from acommercial source.

Example 2

Body Lubricating Composition

A sample prototype composition of the instant disclosure was formulatedas an aqueous solutions containing a mixture of mucilage extracted fromokra (Abelmoschus esculentus or Hibiscus esculentus) powder; Rubusidaeus (raspberry) seed oil; Citrus unshiu peel extract; Aloebarbadensis leaf juice; cocamidopropyl betaine; disodium laurethsulfosuccinate; decyl glucoside; disodium cocoamphodiacetate; glycerin;caffeine; Sodium Phytate; hydrolyzed soy protein; phenoxyethanol;ethylhexylglycerin; sodium chloride; sodium lactate; potassium chloride;and calcium chloride.

The okra mucilage provides the main lubricating and moisturizing qualityof the formulation. The acceptable concentration range for the okrapowder mucilage is of 0.001-5.0% (w/v). In addition to powdered okra, itwould be possible to extract the mucilage in the formulated compositionfrom fresh, frozen, or dried okra.

The formulation was preferentially buffered to a pH range of about 5.5to 8.0, with a preferable pH of about 6.5. The buffering wasaccomplished with a combination of sodium chloride; sodium lactate;potassium chloride; and calcium chloride. The concentration ranges ofeach salt used to attain the desired pH in question were as follows:sodium chloride: 0.3-2.0%; sodium lactate: 0.2-2.0%; potassium chloride:0.01-2.0%; and calcium chloride: 0.01-2.0%.

In an embodiment, the following agents were incorporated as surfactantsin the formulations at the given concentration ranges: cocamidopropylbetaine (1.0-12%); disodium laureth sulfosuccinate (1.0-12%); decylglucoside (1.0-12.0%); disodium cocoamphodiacetate (0.1-4.0%); andglycerin (0.008-0.5%). The glycerin provides a dual role in theformation in that it also acts as an emollient. Aloe barbadensis leafjuice was also added as another emollient at a concentration range of0.05-4.0%.

In an embodiment, Rubus idaeus (Raspberry) seed oil and Citrus unshiupeel extract were included for their antioxidant properties. Theraspberry seed oil was added in concentration range of 0.001-5.0%, whilethe Citrus unshiu peel extract was present at concentrations of0.01%-1.0%.

In an embodiment, caffeine, at concentration range of 0.05-0.5%, wasused as an antioxidant. In an embodiment, sodium phytate, a chelatingagent, and was added at a concentration range of 0.02-1.0%. In anembodiment, hydrolyzed soy protein at a concentration range of0.025-3.0% was added as an additional moisturizer.

In an embodiment, ethylhexylglycerin was included as both a moisturizerand a preservative at a concentration range of 0.001-1.0%. In anembodiment, the phenoxyethanol was also used as a preservative atconcentrations of 0.01-1.0%. In an embodiment, fragrance can be added atconcentrations up to 0.25%.

Following the addition of the above components, the remaining aqueousportion of the above described formulation can range from 60-95%.

Example 3 Anti-Inflammatory and Anti-Pain Composition

A sample prototype composition of the instant disclosure was formulatedas an aqueous solutions containing a mixture of mucilage extracted fromokra (Abelmoschus esculentus or Hibiscus esculentus) powder; Rubusidaeus (raspberry) seed oil; Citrus unshiu peel extract; Aloebarbadensis leaf juice; cocamidopropyl betaine; disodium laurethsulfosuccinate; decyl glucoside; disodium cocoamphodiacetate; glycerin;caffeine; Sodium Phytate; hydrolyzed soy protein; phenoxyethanol;ethylhexylglycerin; sodium chloride; sodium lactate; potassium chloride;and calcium chloride.

The okra mucilage provides the main lubricating and moisturizing qualityof the formulation. The acceptable concentration range for the okrapower mucilage is of 0.001-5.0% (w/v). In addition to powered okra, itwould be possible to extract the mucilage in the formulated compositionfrom fresh, frozen, or dried okra. The extract can be made from theseed, root, capsule, leaves, or any combination thereof.

The formulation was preferentially buffered to a pH range of 5.5 to 8.0,with a preferable pH of about 6.5. The buffering was accomplished with acombination of sodium chloride; sodium lactate; potassium chloride; and,calcium chloride. The concentration ranges of each salt used to attainthe desired pH in question were as follows: sodium chloride: 0.3-2.0%;sodium lactate: 0.2-2.0%; potassium chloride: 0.01-2.0%; and calciumchloride: 0.01-2.0%.

The following agents were incorporated as surfactants in theformulations at the given concentration ranges: cocamidopropyl betaine(1.0-12%); disodium laureth sulfosuccinate (1.0-12%); decyl glucoside(1.0-12.0%); disodium cocoamphodiacetate (0.1-4.0%); and, glycerin(0.008-0.5%). The glycerin provides a dual role in the formation in thatit also acts as an emollient. Aloe barbadensis leaf juice was also addedas another emollient at a concentration range of 0.05-4.0%.

Rubus idaeus (Raspberry) seed oil; and, Citrus unshiu peel extract wereincluded for their antioxidant properties. The raspberry seed oil wasadded in concentration range of 0.001-5.0%, while the Citrus unshiu peelextract was present at concentrations of 0.01%-1.0%.

Caffeine, at concentration range of 0.05-0.5% was used an antioxidant.Sodium Phytate, a chelating agent, and was added at concentration rangeof 0.02-1.0%. Hydrolyzed soy protein at concentration range of0.025-3.0% was added as an additional moisturizer.

Ethylhexylglycerin was included as both a moisturizer and a preservativeat a concentration range of 0.001-1.0%. The phenoxyethanol was also usedas a preservative at concentrations of 0.01-1.0%. Fragrance can be addedat concentrations up to 0.25%.

Following the addition of the above components, the remaining aqueousportion of the above described formulation can range 60-95%.

Example 4 Wipes

For convenience, cotton pads were impregnated with the above aqueous.The pads provide a more convenient method of applying the formulation.These pads are especially useful as eye wipes. In an embodiment, thepads can be comprised of including but not limited to cotton, paper,tissue, fiber, non-woven fabric, plastic, or polyester.

Example 5 Application of the Formulation to a Biological Tissue.

The lubricating and moisturizing formulation provided herein acts as alubricating, moisturizing and protective barrier to the tissues to whichit is applied. These effects are illustrated in FIG. 1. The unprotectedtissue shown on the left is susceptible to both water loss and assaultfrom foreign particles and UV rays. The application of the lubricatingand moisturizing formulations of the instant disclosure result in aprotective layer of mucilage being applied to the surface of the tissueto which it applies. This layer provides a barrier against UV rays andforeign particles. In addition, the resulting barrier prevents waterloss from the tissue in question, thereby acting as a moisturizer.

Example 6

Results of Using the Formulation

The formulation has been shown in a clinical in vitro study to killocular Demodex mites. The aim of the study was to determine the efficacyof ZocuFoam™ Eyelid Cleanser & Moisturizer at killing Demodex mites. Thecontrol was preservative-free saline and the topical agent was ZocuFoam™Eyelid Cleanser & Moisturizer. Patients who exhibited cylindricalsleeves on their lashes were selected and a slit lamp exam was performedto determine which lashes would be epilated. The lashes were thenimmersed in an agent and examined with a light microscope. The presenceof Demodex was determined and the amount of time for the agent tocompletely kill the Demodex mite was noted. Kill time was determined bythe cessation of leg movements of the mites for a period of 10 minutes.On average, ZocuFoam™ and preservative-free saline killed Demodex in91.11±38.15 and 1129.78±158.38 minutes (p=0.001), respectively.ZocuFoam™ effectively killed Demodex significantly faster thanpreservative-free saline. In an embodiment, the ingredients of ZocuFoam™are water, cocamidopropyl betaine, disodium laureth sulfosuccinate,decyl gluoside, disodium cocoamphodiacetate, Aloe barbadensis leafjuice, Rubus idaeus seed oil, Citrus unshiu peel extract, Hibiscusesculentus powder, caffeine, sodium phytate, hydrolyzed soy protein,glycerin, ethylhexylglycerin, phenoxyethanol, fragrance.

Blepharitis is an inflammation of the eyelids that causes redness,irritation, an itchy sensation, and the formation of dandruff-likescales on eyelashes. It involves inflammation of the eyelid margin wherethe eyelashes are attached and causes irritation, redness, and tissuedamage. Many causes of blepharitis, both anterior and posterior, havebeen described; however the current study is particularly concerned withocular Demodex infestation.

Of the many species of Demodex mites known to exist, Demodexfolliculorum and Demodex brevis are the only two found living on thehuman body. D. folliculorum is primarily found in hair follicles, whileD. brevis is found associated with sebaceous and meibomian glandsconnected to hair follicles (Gao et al., Brit. J. of Ophthal. (2005)).Both species generally inhabit areas on the face, near the nose,eyelashes, and eyebrows, but they can also occur elsewhere on the body.

Patients with blepharitis often present with cylindrical dandruff ontheir eyelashes. FIG. 3A-3D. Cylindrical dandruff (CD) are scales thatform clear cuff collars around eyelash roots (Gao et al., Invest.Ophthal. & Visual Sci. (2005)). This is often indicative of the presenceof ocular Demodex because it is regarded as pathognomonic of Demodexinfestation (Gao et al., Invest. Ophthal. & Visual Sci. (2005)). An okraeyelid patch has been shown to have anti-demodectic effects (Liu andGong, Experimental and Therapeutic Medicine (2021)).

Materials included 0.9% preservative-free saline (Hospira, Inc.,Lakeforest, Ill.) and ZocuFoam™ Eyelid Cleanser & Moisturizer (OkraLimited, Cypress, Tex.) (water, cocamidopropyl betaine, disodium laurethsulfosuccinate, decyl gluoside, disodium cocoamphodiacetate, Aloebarbadensis leaf juice, Rubus idaeus seed oil, Citrus unshiu peelextract, Hibiscus esculentus powder, caffeine, sodium phytate,hydrolyzed soy protein, glycerin, ethylhexylglycerin, phenoxyethanol,fragrance).

The study was conducted at the Cross Eye Centers according to the tenetsespoused in the Declaration of Helsinki. A total of 9 patients wereselected, who displayed evidence of anterior blepharitis. A slit lampwas used to examine the patient population to determine that thoseselected evinced cylindrical dandruff around at least 8 eyelashes. Basedon previous studies, cylindrical dandruff on 8 eyelashes is sufficientto indicate a modest infestation of ocular Demodex. The patientselection was not exclusive based on age, ethnicity, or gender. The onlypatients excluded from the study were those who were currently on a teatree oil treatment regimen or those who had undergone fluoresceinstaining. This exclusion was made because the Demodex derived from thesepatients might exhibit a shortened survival time due to prior exposureto these agents.

One affected eyelash from each fourth of the upper eyelids was epilatedusing a jeweler's type forceps and a slit lamp microscope (Haag-Streit,Bern, Switzerland). Using this method, 43 lashes were collected—18 ofwhich exhibited Demodex.

Each individual eyelash was placed on a microscope slide and immediatelysaturated with 20 μL of either ZocuFoam™ or preservative-free saline. Aplastic coverslip was then placed over the mixture and the slide wasexamined. Under the microscope, the presence of living adult Demodex wasexamined. Confirmation of the mites' live status was evidenced byvigorous movement of their four pairs of legs. Adult Demodex isdistinguishable from juvenile Demodex because of its well-formed legs,stumpy body, and length of approximately 0.4 mm (Gao et al., Invest.Ophthal. & Visual Sci. (2005)).

Once the determination was made that mites were present and alive on theslides, the mites were observed every 15 to 30 minutes to check forobvious signs of reduction of leg movement. When it became apparent thatonly one of its legs was moving irregularly, the mite under observationwas watched continuously until its leg ceased to move.

The mites were observed for a period of 10 additional minutes followingthe cessation of leg movement in order to establish the accuracy of therecorded kill time. Kill time is calculated as the time between exposureof the mite to the agent and cessation of mite leg movement for a periodlonger than 10 minutes.

Demodex were excluded from the study if they did not have vigorous legmovements at the beginning of observation or if more than half of theirbodies were encased in cylindrical dandruff. FIG. 4 depicts a view ofDemodex folliculorum adult and egg forms located on an eyelash follicle.

TABLE 3 Resultant mean kill time of the test agents ZocuFoam ™Preservative-free Saline (mean ± SD) (mean ± SD) Mean kill time(minutes) 91.11 ± 38.15 1129.778 ± 158.38 N = number of Demodex mites 99

Results from a t-test used to analyze the data shows a significantdifference in kill time of the Demodex between ZocuFoam™ andpreservative-free saline (p<0.0001). Table 3.

In this in vitro study of the effects of applying topical and eyelidcleansing agents to Demodex derived from patients with anteriorblepharitis, ZocuFoam™ is effective in eradicating the mites in a timelymanner when compared to saline. ZocuFoam™ was able to kill the Demodexon average in 1.52 hours. The preservative-free saline was able to killthe Demodex on average in 18.83 hours.

According to Gao (Gao et al., Brit. J. of Ophthal. (2005)), Tea Tree Oil(TTO) stimulates Demodex to migrate out of cylindrical dandruff casingsembedded in the skin, allowing them to encounter the oil. Although it isunderstood that TTO is a very effective cleansing agent, its use amongpatient populations may not be as high as expected because TTO acts asan irritant if it enters a patient's eyes. This issue may becircumvented if patients are warned beforehand to tightly seal theireyelids before applying the oil.

The ZocuFoam™ scrub is especially helpful for patients who experienceallergic reactions to various components of the TTO solution, such asEucalyptus. This regimen is effective in killing and reducing Demodexpresence. FIG. 5.

Example 7

An in-office eyelid debridement using a okra-based polysaccharide gelwas performed to evaluate the gel for dry eye relief. Evaluation wasperformed using a SPEED questionnaire. Subjects with a SPEED Score over6 and who were 18 years or older were eligible for this study. Exclusioncriteria included smoking, pregnancy, active ocular infection orintraocular inflammation, recent eye surgery within the previous 3months, or prior isotretinoin use. SPEED scores were taken at baselineand at 2 hours following bilateral eyelid debridement using the ZocuKit™System containing the okra-based polysaccharide gel. At baseline, themean SPEED score was 11.3±0.7 in 9 subjects. FIG. 6. Two hours aftereyelid debridement with an okra-based polysaccharide gel, the mean SPEEDscore improved to 0.7±0.3 (p<0.0001). FIG. 6. The results demonstrate animprovement in all treated subjects with moderate to severe dry eyesymptoms using an okra-based polysaccharide gel for controllinginflammation at the eyelid margin. Schachter. The SPEED questionnaireassesses pain via the score for soreness and burning.

Example 8

The purpose of these tests were to evaluate contact lens discomfort(CLD) associated with meibomian gland disfunction (MGD) using theZocular Eyelid System Treatment (ZEST) protocol. ZEST was performed inall eyelids on thirty CLD patients with MGD (26.5+/−7.51 years) on thefirst visit. Patients reported the number of hours of contact lens (CL)wear per day (FIG. 7C) and completed the CLDEQ-8 questionnaire (FIG. 7A)prior to treatment and at 2-weeks and 1-month post treatment. A Quidel®Inflammadry® MMP-9 test was done prior to and 1-month post-treatment.FIG. 7D. Non-invasive tear break-up (NITBUT) was measured at each visit.Ocular Surface Disease Index (OSDI) scores were measured prior totreatment and at 2-weeks and 1-month post treatment. FIG. 7B. Data wasanalyzed by paired samples t-test. Narayanan et al. The OSDIquestionnaire assesses pain via a sore eyes question.

Any patents or publications mentioned in this specification areindicative of the levels of those skilled in the art to which thedisclosure pertains. These patents and publications are hereinincorporated by reference to the same extent as if each individualpublication was specifically and individually indicated to beincorporated by reference.

Changes therein and other uses will occur to those skilled in the artwhich are encompassed within the spirit of the disclosure as defined bythe scope of the claims.

REFERENCES

The following references were cited herein:

-   U.S. Pat. No. 4,014,335, Arnold, Randall K., Ocular Drug Delivery    Device, Mar. 29, 1977.-   U.S. Pat. No. 4,154,822, Polimeni et al., Polysaccharide for    Enhancement of Cardiac Output, May 15, 1979.-   U.S. Pat. No. 5,851,963, O'Bryant, Jeffrey Charles. Organic    Lubricant, Dec. 22, 1998.-   U.S. Pat. No. 6,124,248, O'Bryant, et al., Organic Lubricants and    Coolants, Sep. 26, 2000.-   U.S. Pat. No. 8,628,816, Henry et al., Product to reduce glycemic    response of carbohydrate based foods, Jan. 14, 2014.-   U.S. Pat. No. 9,163,374, Alcantar, et al., Use of cactus mucilage as    a dispersant and absorbent for oil in oil-water mixtures, Oct. 15,    2015.-   US Patent Application No. 20140303094, Bastia et al., Composition    and Use Thereof in the Treatment of Anal Rhagades, Oct. 9, 2014.-   Sindhu, G.; Ratheesh, M.; Shyni, G. L.; Nambisan, B.; and Helen, A.,    Anti-inflammatory and antioxidative effects of mucilage of    Trigonella foenum graecum (Fenugreek) on adjuvant induced arthritic    rats, Intl. Immunopharm. 12: 205-211 (2012).-   Cosmetic Ingredients Database, available at    http://www.rsc.org/education/teachers/Resources/aflchem/resources/39/39%20resources/39-2%20database.pdf.-   Farooq, U.; Malviya, R.; and Sharma, P. K., Extraction and    Characterization of Okra Mucilage as Pharmaceutical Excipient,    Acad. J. Plant. Sci. 6(4):168-172 (2013).-   Gao Y Y, Di Pascuale M, Li W, et al., In vitro and in vivo killing    of ocular Demodex by tea tree oil. British Journal of Ophthalmology    2005, 89: p. 1468-1473.-   Gao Y Y, Di Pascuale M, Li W, et al., High Prevalence of Demodex in    eyelashes with cylindrical Dandruff. Investigative Ophthalmology &    Visual Science. 2005, 46(9): p. 3089-94.-   Inceboz T, Yaman A, Over Leyla, et al., Diagnosis and Treatment of    Demodetic Blepharitis. Turkiye Parazitoloji Dergisi. 2009, 33(1): p.    32-36.-   Narayan S, Bendert E, Owen K, Zamaron T, Lopez C, and Kasraie N,    ZEST—Zocular Eyelid System Treatment—improves contact lens    discomfort caused by MGD, Poster at Optometry's Meeting.-   Schachter S, Novel Okra Polysaccharide Approach to Inflammation    Control for Dry Eye, ARVO Study.-   Liu and Gong, Experimental and Therapeutic Medicine, 2021, 21: p.    338-345.

What is claimed is:
 1. A formulation for treating inflammation in abodily tissue comprising: a mucilage extracted from Abelmoschus, whereinsaid mucilage is present in the formulation at a concentration of0.001%-5.0% (w/v); one or more emollients, wherein said emollients areselected from the group consisting of Aloe barbadensis leaf juice andglycerin; and one or more antioxidants, wherein said antioxidants areselected from the group consisting of Rubus idaeus seed oil and Citrusunshiu peel extract.
 2. The formulation of claim 1, wherein the mucilageis extracted from Abelmoschus esculentus.
 3. The formulation of claim 2,wherein the mucilage is extracted from plant material selected from thegroup comprising fresh plant material, frozen plant material, driedplant material, and powdered plant material.
 4. The formulation of claim3, wherein the Abelmoschus esculentus mucilage is extracted frompowdered okra.
 5. The formulation of claim 1, further comprising one ormore surfactants.
 6. The formulation of claim 5, wherein the one or moresurfactants are selected from the group consisting of disodium laurethsulfosuccinate, decyl glucoside, cetalkonium chloride, disodiumcocoamphodiacetate, and glycerin.
 7. The formulation of claim 1, furthercomprising caffeine as an antioxidant; sodium phytate as a chelatingagent; hydrolyzed soy protein as a moisturizer; ethylhexylglycerin as aconditioning agent and preservative; and phenoxyethanol as apreservative.
 8. The formulation of claim 1, wherein the formulation isprovided in a form selected from the group consisting of a wipe; a swab;a bandage; a gauze; a suspension; a foam; a gel; and a spray.
 9. Theformulation of claim 8 wherein the formulation is a gel.
 10. Theformulation of claim 1, wherein the formulation is buffered to a pHrange of about 5.5 to 8.0.
 11. The formulation of claim 10, wherein theformulation is buffered to a pH of about 6.5.
 12. The formulation ofclaim 10, wherein the formulation is buffered with one of more saltsselected from the list comprising sodium chloride, sodium lactate,potassium chloride, and calcium chloride.
 13. The formulation of claim12, wherein the formulation further comprises one or more cationic,anionic, nonionic, or amphoteric surfactants.
 14. A formulation fortreating pain in a bodily tissue comprising: a mucilage extracted fromAbelmoschus, wherein said mucilage is present in the formulation at aconcentration of 0.001%-5.0% (w/v); one or more emollients, wherein saidemollients are selected from the group consisting of Aloe barbadensisleaf juice and glycerin; and one or more antioxidants, wherein saidantioxidants are selected from the group consisting of Rubus idaeus seedoil and Citrus unshiu peel extract.
 15. The formulation of claim 14wherein the formulation is an anti-pain formulation comprisingAbelmoschus esculentus mucilage; Rubus idaeus seed oil; Citrus unshiupeel extract; Aloe barbadensis leaf juice; sodium phytate;phenoxyethanol; and ethylhexylglycerin; and wherein the formulation isbuffered to a pH range of about 5.5 to 8.0.
 16. The formulation of claim14 wherein the formulation is a gel.
 17. A method of treatinginflammation in a bodily tissue comprising: preparing the formulation ofclaim 1; and applying the formulation to the bodily tissue in need ofinflammation treatment.
 18. A method of treating pain in a bodily tissuecomprising: preparing the formulation of claim 14; and applying theformulation to the bodily tissue in need of pain treatment.
 19. A methodof treating pain in a bodily tissue or an inflamed bodily tissuecomprising: applying to the bodily tissue in need of pain treatment orthe inflamed bodily tissue a formulation comprising Abelmoschusesculentus mucilage; Rubus idaeus seed oil; Citrus unshiu peel extract;Aloe barbadensis leaf juice; disodium laureth sulfosuccinate; decylglucoside; disodium cocoamphodiacetate; glycerin; caffeine; sodiumphytate; hydrolyzed soy protein; phenoxyethanol; ethylhexylglycerin;sodium chloride; sodium lactate, potassium chloride, and calciumchloride; and wherein the formulation is buffered to about pH 6.5. 20.The method of claim 19 wherein the formulation is absorbed through theskin.